Prostate Cancer Clinical Trial
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Summary
This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI >25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed prostate adenocarcinoma
Most recent biopsy positive for prostate cancer
Currently on or starting active surveillance
Ability to read, write, and understand English
BMI >24 kg/m2
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
Age > 18 years
Exclusion Criteria:
Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
Loss of >10% of body weight within the previous 6 months
Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
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There is 1 Location for this study
Los Angeles California, 90048, United States
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